Breo Ellipta

The recommended adult dose of fluticasone - vilanterol to treat COPD is one inhalation of 100 µg/25 µg once daily, at the same time every day.

When treating asthma, the recommended adult dose of fluticasone - vilanterol is one inhalation of 100 µg/25 µg or 200 µg/ 25 µg inhaled once daily, at the same time every day.

After inhaling the dose of medication, rinse your mouth with water and spit it out, to reduce the chances of developing thrush.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Breo Ellipta be taken exactly as prescribed by your doctor.

Read the package insert or speak with your pharmacist for instructions on using the dispenser properly.

To make sure the medication remains effective, it is very important to use it regularly once a day, exactly as prescribed by your doctor, even when you are not experiencing symptoms of COPD or asthma. To prevent side effects, do not use Breo Ellipta more often than prescribed.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Breo Ellipta at room temperature, protect it from light and moisture, and keep it out of the reach of children. Discard any remaining medication 6 weeks after removing the inhaler from the foil package.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause an infection of the mouth or throat, known as thrush; it may cause headaches; it may cause sore throat. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 µg/25 µg
Breo Ellipta is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 100 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.

200 µg/25 µg
Breo Ellipta is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 200 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.

Do not use Breo Ellipta if you:

• are allergic to fluticasone, vilanterol, or any ingredients of the medication
• are allergic to lactose or milk protein
• are having an asthma attack with sudden shortness of breath or wheezing

There may be an interaction between fluticasone - vilanterol and any of the following:

• Aldesleukin
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• amphotericin B
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• Atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG vaccine
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Betahistine
• caffeine
• cannabis
• chloroquine
• Cobicistat
• conivaptan
• Cyclosporine
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• Deferasirox
• Denosumab
• Desmopressin
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Diltiazem
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dofetilide
• Domperidone
• Dronedarone
• echinacea
• Epinephrine
• fast-acting beta-2 agonists (e.g., salbutamol, fenoterol, terbutaline)
• Fingolimod
• Flecainide
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• hyaluronidase
• Leflunomide
• Linezolid
• Lomitapide
• other long-acting beta-2 agonists (e.g., formoterol, Indacaterol, salmeterol)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Nabilone
• Natalizumab
• Nivolumab
• pentamidine
• Pimecrolimus
• Primaquine
• procainamide
• protein kinase inhibitors (e.g., Ceritinib, Crizotinib, Dasatinib, Idelalisib, Nilotinib, imatinib, Sunitinib, )
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Tacrolimus
• Tetrabenazine
• Tetracycline
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tofacitinib
• Trastuzumab
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• vaccines
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Breo Ellipta. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Breo Ellipta.

Asthma-related deaths: When used for asthma treatment, another medication in the same class as vilanterol (LABAs) has been linked to an increase in asthma-related deaths. The use of inhaled corticosteroids, such as fluticasone, with LABAs appears to reduce the risk of serious asthma-related events. If you experience worsening symptoms or your "rescue" medications are not as effective as usual, contact your doctor or seek medical attention immediately.

Diabetes: Breo Ellipta may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Breo Ellipta.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Eye problems: Fluticasone may increase the risk of developing cataracts or glaucoma. If you are at risk of developing either of these conditions, have your eyes checked by your doctor before starting long-term treatment with Breo Ellipta. You should have your eyes monitored at regular intervals while using Breo Ellipta.

Heart conditions: Vilanterol may cause increased blood pressure, rapid heart rate or irregular heart rhythms, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), high blood pressure or other heart disease, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Infections: Breo Ellipta, like other corticosteroids, may prevent the early signs of a serious infection from being noticed. Try to limit the amount of time you spend around others who have recently had infections such as Chickenpox or Measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice.

Liver function: Liver disease or reduced liver function may cause fluticasone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Oral hygiene: Fluticasone may cause thrush infection in the mouth and throat. Adequate oral hygiene is very important in minimizing the overgrowth of microorganisms such as Candidiasis (thrush). To reduce the risk of infection, gargle with water after each use of Breo Ellipta.

Osteoporosis: Long-term use of medications like fluticasone may increase your risk of developing osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Pneumonia: People using fluticasone-vilanterol to treat COPD may be at an increased risk of developing pneumonia. If you experience symptoms of pneumonia, such as fever, chills, shortness of breath, cough or chest pain, get medical attention as soon as possible.

Seizures: People with seizure disorders may be more likely to experience side effects of vilanterol. If you have a seizure disorder, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Steroid medication use: If you have taken or are still taking oral steroid medications over the last several months, consult with your doctor before using Breo Ellipta. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.

Thyroid problems: People with thyroid conditions may be more likely to experience side effects of vilanterol. If you have an overactive thyroid gland, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Wheezing: Breo Ellipta may cause the airways to spasm immediately after using the inhaler. If this happens, use your rescue inhaler as soon as possible to relieve the symptoms, then call your doctor as soon as possible.

Pregnancy: Breo Ellipta should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Breo Ellipta, contact your doctor immediately.

Breast-feeding: It is not known if fluticasone - vilanterol passes into breast milk. If you are a breast-feeding mother and are taking Breo Ellipta, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Breo Ellipta is not intended for use by children. The safety and effectiveness of using Breo Ellipta have not been established for children or people under the age of eighteen.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. Using this product may cause throat irritation and coughing. You can avoid these problems by thoroughly rinsing your mouth and gargling after each dose. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first.